CTSO - Earnings call transcript Q3 2020 | Cytosorbents Corporation

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Operator

Good afternoon and welcome to the CytoSorbents' Third Quarter 2020 Financial and Operating Results Conference Call. At this time all participants are in a listen-only mode.

Following the formal remarks we will open the call for your questions. Please be advised that the call will be recorded at the company's request. At this time, I would like to turn the call over to our moderator, Jeremy Feffer. ahead. go Please

Jeremy Feffer

Financial Executive and XXXX Stacy me Welcome CytoSorbents' Chan, to from Officer Chief Thank Efthymios Christopher of and; Director Bloch, and Business Steiner, GMBH; Medical and good operating quarter Christian Vice Deliargyris, Cytosorbents Officer; President Development. Managing Chief Chief Kathleen Phillip Vice Dr. financial Marketing President company and Joining Chief Dr. Vincent Cramer, of Senior of results third Officer; Capponi, Dr. Sales and the Operating you, are afternoon. Officer; conference today Europe call

Dr. response Before during I'd I Company Therefore, in for Actual turn questions may remarks which the call Securities Safe management's and the Harbor call today to to from differ over and company's to projections of you as may XXXX. a uncertainties we results forward-looking today, may by with as to that claims statements SEC. under the Reform make the to results refer uncertainties. listeners contained subject Any forward-looking in in Litigation statements forward-looking Private discussion risks and represented statements the Chan, projections more these today. include are remind company's prepared contain protection of like change. of therefore, your update to management conditions and the filings detailed risks market we the Management performance Act X, November in XXXX, assume estimates to future obligation additional future no as these discussed the

for Chan highlights overview we the call, and covering and third financial by today's have quarter an Dr. presentation During will Ms. Bloch. operating

to At questions, management Phillip the live Chan. open will the session time, to call my the Phil? we during pleasure team. it's rest over the Q&A of turn presentation, line to Dr. with their your the this Following

Phillip Chan

very marked quarter had We earnings accomplishments. you third by for an quarter outstanding welcome third everyone the XXXX Jeremy to Cytosorbents numerous much and Thank call Corporation.

$XX.X sales XX-month to grew million million XX% third Trailing million. grew to $XX.X $XX.X revenue the total XXXX over product XX% sales were and XXXX. quarter third First, product of quarter

delivered and XXX,XXX we our up Cytosorbents cummalative delivered. XXX,XXX of than more up year from ago a recently Secondly, a XX% announced achieving more devices from milestone than XX,XXX today,

with also strengthening blended third a July, the following committee financing gross quarter monitoring XX% completed a end resumption margin We Leerink our we Riley B. than REFRESH The Cowen roughly favorable of to cost second ago, this the data. higher of million of COVID-XX a recommended year $XX also SVB million margins lower third cash FBR $XX.X XX% year balance due percentage of sequentially data product higher and co-manager achieved in but to in to quarter safety production. X distributor XX% compared the of In of and sales the led rents higher by quarter. review the trial at the

COVID-XX more these including of have capture terms the patients working are COVID-XX CTC estimated in countries seeking now here an COVID-XX the States, we to in the world, than and data In United XX registry. around X,XXX in

and commercialize as to currently. and Cardiovascular, and well other cover States the CytoSorb collaborations established states in Terumo states with Surgical the also We InvoSurg, United working to XX are Partners

we And development. were for use areas. are number demand drive One strong CytoSorb, initiatives this leaders in current two These and sales. and a We of to for opinion for growth. is $X.X cash expanded of key the Antibody And the Brazil. with in a webinar Drug clinical application key CytoSorb of webinar we for the pull from to a also complete July. executing are the including hosted to also trials. HemoDefend-Blood and countries, on pre-clinical performance Antithrombotic million We distribution with contract awarded second With use our on also position, coupled CytoSorb strong Group major solid XX financial Removal and users anticipated is DoD a commercialization, of CytoSorb key

On this is world the wave. maximize one positioned the and opportunity. to We're Europe throughout well growth the our of to help in next COVID-XX sales first strategy goals side, in

We also have established the the States, collaboration establishing key throughout relationships in country. United

today. plan fades, Second detailed pre COVID-XX, approval to expected of This is vaccines growth press all, year as of COVID-XX our very to in which happen our for COVID-XX next is with strategy. the return release we extensively to

with as and help to to COVID-XX streamline VP other to also applications. clinical such over the debt E.U. in with a helping able refinancing But potential thereby million particular, prepare for on strategy, Ticagrelor applications, involves in like either products program. our the So in next feature Chief disease, manufacturing, I'd the to for R&D. you Rivaroxaban may then of us but as drive Dr. endocarditis focus on I'll new expansion of key hiring tenants gross international Efthymios States such applications commercialization, our able to other the $XXX cardiac removal in focus sales expand expand the to and to also only currently Officer. and to sheet that, to million our on the up with of of of sales, commercialization, Sales mute. produce to and process come the Ticagrelor which and be and to to to prepare plan, To very team also driving clinical maximize focus recurrent the to strategy scale, applications or direct to $XXX the expand be on Deliargyris, that And blended for new our manage distributor of sales, States, turn briefly, our Medical on balance I'd order be cover like a And are liver surgery, if underway. Makis, is United approvals, it of of United that, to and repayment both and with to this and to product level a approved but more as such get margins, finally, the somewhere

Efthymios Deliargyris

note, Thank activities me you, on for I'm Apologies. been And a Company. able be to with very our clinical to to pleased the On and for to overview it's personal the a our of call. going you afternoon months clinical exciting Phil. very present And good everyone six with today the plan forward.

I've plans. this spend clinical six the extensive During chance CytoSorbents, with within last colleagues finalize to months, and had prioritize targets my our our time

COVID-XX detail our During clinical to for now the finally, clinical have encounter but clinical with significant already funds later, that and more execute we hear time, a you the we COVID-XX ambitious an from clinical to as faced activities. from you we'll significant heard Kathleen you're across we And about opportunities, programs, little related Phil, and on available later our expand also going and discuss plan. challenges in capabilities

that that noted of today and As this on cardiac we care, seeing and in a of areas specifically therapeutic slide, Europe, Cytosorbents surgery. we're focus and cardiovascular area applications practice critical will on is both disease,

we six very and will have target civilization. care therapeutic the programs. areas be In clinical where cytokines rapid our shock device by that specific We with hemodynamic can will identified CytoSorb reversal, effective we focus removing priority critical providing on space,

bilirubin applications focus will as cytokine can with liver with in course extremely liver this removal or effective the in clinical also patients. failure ammonia, of liver We a be the and coupled on reversing acute toxins removal

very quenching cytokine the removal setting slide, efficient clinical ATR these our with in especially on a shown in three focus continue activities COVID-XX antithrombotic antithrombotic removal, on in the the substantial where our where operating ready also with will targets will specific as space, have known to arena, storm agents We cardiovascular evidence, a CytoSorb combined bench the far. a by and CytoSorb clinical we ECMO of room. clinical of the benefits expand therapy so has again, the In

course, high cardiac cytokine will ill will clinical in complex mortality in hemodynamic undergoing with focus stabilization of surgery. to could also preventing removal faced lead continue clinical We acute on otherwise. patients kidney And in acutely endocarditis, benefits this our injury patients and we program substantial with

We the implement approach. complimentary will

Registry U.S, to United acute injury large kidney multicenter prevention also CyTATION initiate in cardiac REFRESH into will focused the removal of therapy Germany. Germany. note with trial Ticagrelor in multicenter single a trial in registries, prospective next single looking CTC trial acute shock already trials, ticagrelor The three these designs the Early generation, reversal this study U.S. the single-arm antithrombotic randomized company XXXX, to plan or oral also clinical XX in executed removal in in and surgery, Programs the associated And in study Registry Ticagrelor X removal programs. and trials initiate is in reversal are COVID-XX, sponsored Germany. TISORB study called with to and heavily type programs initiated Germany, center a trials we data going. including including then trials. both Study our anticoagulant STAR that, in clinical randomized like on-chronic The implement liver will clinical and second States. HepOnFire, you innovative slide, on the Although table substantial complement shock in in in in other on after trial follow-up next including execution in the the we the the On a also trial patients plan liver months in we the randomized multicenter PK-PD in arm and finally, failure, again, U.S. the novel clinical trials the process, In randomized executed

Next slide.

slide There's of delay. please. Next a a bit

trial we'd In a X approval, with pivotal to and to addition, provide path ticagrelor to like a be to our FDA removal. we'll dual updates. breakthrough path some continue specific Relating designation on REFRESH the and you

we fronts. quarter, both third progress the During made on

during we ticagrelor of we to and believe with resumption regulatory first who the significant surgery. FDA patients aligned the recent quarter designation, already very Specifically we medical heard, pending and in you we delays, reviewed continuation major forward specifically, close designation trial for was in made on the cardiothoracic from are monitoring our without agency were related In first the the study fully that that The with progress enrollment both commence emergent ticagrelor and already again path been that committee More that's to discussions analysis a unmet by during and believe the our that have urgent interim modifications. the completed we in REFRESH consistent breakthrough COVID-XX XXXX. enrolled XXX relation to teleconference, X, need breakthrough will has remove status. significant data process study safety an the as recommended initiated the with data patient

including the data which title positive We in that of that U.K., additional the application, together by support discuss also very the reviewed profile this of studies data will we is our in risk and for CytoSorb believe provided study us be with despite and with the study. shortages the provided challenges related finally, designation COVID-XX that this breakthrough Germany, will CyTATION And team resource FDA, a and review with which for work speed assurances consistent necessary indications. the urgency they benefit at

Non the with on study, prioritization address to is sites a continue activities clinical vaccine working to challenged our feasible. of as which these related lockdowns, either diligently TISORB Moving Regardless, U.K, to challenges team and removal is institutional COVID-XX soon as or trials. related ticagrelor study. R&D, commence COVID-XX be related clinical to in U.K. CytoSorb enrollment

REMOVE onto Moving trial. the clinical randomized

as This As that investigates detailed line the undergoing worldwide. scientific end, data top we remain the international of before government results applies and in first contact control related at diligently study infective the challenge suffering in possible. close for we already surgery of valve that We XXXX. data as be as the randomized patient who have endocarditis. the presented discussed, may investigators results in meaning trial are soon delays to available German in line XXX this year's investigator and patients working COVID-XX and Despite as from to funded submitted with top believe completed has replacement analysis, publication a sponsored and monitoring for been use CytoSorb’s half the data early also COVID-XX

to countries including please. the On also a treat under United world, use slide, States Coronavirus many around the in ill authorization. us in Next note, COVID-XX with critically given has the positive ICUs opportunity emergency patients

a number have been who capture launched an As COVID-XX dedicated patients data this worldwide. initiatives to slide, with XXXX estimated CytoSorb listed of on have treated we from

initial we registry CTC As years is an end. enrolling planned patients analysis with recently for the and live actively from announced, centers U.S.

expanding a to international. step, experienced next registry As we're CTC large with countries the

to all in single consolidate intent a and these from and pooled patients. analysis the that from progress the both high clinical practices Additional are patients data, smaller large experience will to lead of on publications. generate countries sites quality number The use and with data multiple outcomes best of and COVID-XX initiatives CytoSorb is for collection

have series to Phil. case initial back been I reports case it fact, In like that, already would published. and And to with turn

Phillip Chan

call financial Kathy? now very to I'd for that Makis for turn the And overview. Kathy over like to you much, Thank overview,

Kathleen Bloch

Phil. you, And Thank Greetings, everyone.

XXXX talk an for and call, working results. runway. regarding provide financial So about in I'll today's quarter capital our And third update our cash addition, I'll

Next slide.

our for the approximately an quarter sales is So which XXXX. XXXX for over in new orders to increase from $X.X CytoSorb from both sales third of product sales million, of direct million, this in and $X.X an increase $XX.X resulting product sales million driven XX% of an were increase sales QX by and was increase repeat approximately of existing approximately customers customers, also distributor million. $X.X And

third quantify, in million XXXX of XXXX. to it's demand QX rate an And total to product average the estimate exchange treat QX we in positive to on the were quarter that to $X.XX a our approximately of from of due Now Euro difficult rate to of had increased sales $XXX,XXX. for $X dollar this XXXX in XX the sales XXXX COVID-XX approximately patients. third $X.X And did CytoSorb though quarter impact

Our and XXXX, as quarter XXXX of of which million. grant greater was for $X.X compared was represents profit million our XX%. to QX XXXX increase total which third an the $XX.X profit million sales quarter approximately product million the revenues, than which $X.X for gross an third for approximately which increase third XXXX, And is our to quarter of revenue, both XX% of $X.X grew $X.X or million, importantly, includes gross

the sales as to a the result third primarily some margin COVID-XX of in margin distributor as XXXX third an XXXX of of due up gross for Our product of approximately due increase continuing were well efforts compared contribution payments for XX% the as quarter on our to production. XX% to to quarter ramp profit to sales, additional employees incentive lower as percentage

for the is were months once significant results but XXXX, XX% used. U.S. period months Next to at surgery XXXX. sales dollar nine under in have XXXX, XXXX. same sales September FDA due the in do ended related in to rate offset of the that sales COVID-XX million, the of sales been otherwise exchange impact then product quantitate on indicate change cardiac over nine our for during $XX.X not or was which CytoSorb product demand to granted authorization, CytoSorb pandemic, ended use approximately avoided nine slide. as XX in hospitals may postponed an And COVID-XX to approximately difficult procedures compared that decreases treat by to we months for nine States September United in the was have The our some where the the turning to for for patients. period the first which note Sales XX We Euro this we $X.X such the again, a months emergency have And sales the months $XXX,XXX total did were elective financial it's million by in XX XXXX, of to estimated extent September in increase sales XXXX. the of million in were $XX.X increase ended to nine product as same to

slide. Next

patients XXXX, XXXX. impact continue the by sales. quarterly the representing Looking are we at achieved that on and the consecutive record have a pandemic our CytoSorb third treat Sales revenues product for of with we been expect in ICU. sales, product XXXX order currently to we $XX.X another experiencing, sales with that And demand COVID-XX quarter quarter-over-quarter of remainder to third have positive given our product the growth, quarter-over-quarter the growth of will positively impacted sales of the XXXX product quarter of for our fourth product million, COVID-XX in patterns in

However, this contained. future in the be the may pandemic should change

strong. XX-months Next, you product next product our And very, from can chart, slide, be continues we look trailing growth very overall, this at to our as annual sales sales. see

didn't those for related be ramp our adjusted flow. XXXX year-over-year cash look during of to payments employees XX the finally, continue capital up rise related take In for production if and to COVID-XX working would addition, at ramp and we a let's costs. And margins -- have up gross XX% the incentive they in liquidity COVID-XX

mentioned, capital believe, well our And future. in our driving in operating current to a and July as Bank. we've worldwide acceptance to provide to cash, our which growth company. million clinical to is to in a the strategy, benefit $XX increase that spend CytoSorb generated result runway the which our sales, solid We XXXX of of expanding from to we regard we proceeds the needs securing So with a term quarter approval, obtaining operating And equity and Bridge our prior raise, cash beat and take September two, three mention cash existing million position data approximately $XX.X U.S. that and With generating I XXXX, was net foreseeable over capacity, foundation, regard approximately previously at our prioritize production loan one $XX most direct and into now ever standard-of-care. will with had this XX FDA we the as had. the intend million minute want to our also around a

Bank, the to now, refinancing the for these the or as best of extremely as interest Bridge shareholders of with existing in lenders. but a the future, And have of current our company our debt period are the well debt debt, commitment debt availability interest to of amount reputable discussions debt as the the expanding repayment in in of other future. And the we our And finalize near in directors. And with as been extensive deliberating now, of are debt available alternatives financing our existing of are debt the and future. the expect weighing with with very mind, all with regard we current the closely and finalizing to well the repayment comprehensive retaining board a our but financing. alternatives decision limited extending options We regard we in and analysis only include bank, to to not

structure. our capital to turning just Lastly,

call of fully turn XX September a that, like Phil. approximately As XXXX, with million outstanding have I'd to XX.X And on the diluted to basis. we shares common back

Phillip Chan

has much, has you financial terms on guidance Thank historically quarterly very the in completed. specific guidance And quarter until results cytosorbents given of Kathy. now been

order current related However, pattern provided notwithstanding pandemic. uncertainty continues, and the the that COVID-XX to

that quarters of to be XXXX Operator, concludes quarter the remarks. That strongest date. expect current up one the Q&A the open sales We call session. company's please will fourth for our prepared the

Operator

Thank Instructions] go first question Our Petrone you. from Please with ahead. [Operator comes Anthony Jefferies

Anthony Petrone

multiple hope with thanks quarter, and in I quarter COVID I or are bit of good doing million start recent Hi, full case clearances, the light are well. counts on a congratulations do whether how Maybe, where this have you? little emergency authorization use hi, clearances Maybe regulatory in mentioned at everyone's the it's can you the point. X.X just

just I'm follow with think to going, regulatory any deal with additional severe position do are more see wondering we we expecting counts shelf case And I'll clearances? and/or will cases? hospitals you the And have sort on one we themselves how forward stocking when on the having up. be So where CytoSorb of then where is go should geographically, much front, there authorizations as ultimately

Phillip Chan

very seen quarter. centers and, is winter of third of expected season and to of for quarter the we in so a inventory order I have in in ahead be severe fourth difficult flu, COVID-XX, Yes, what that building the advance and think terms

been it's patients mix However, stock and, been the and that most the I ill so two. has for who think currently existing are taken of a of designed has that

the potential world. approvals terms regulatory or emergencies In of throughout other authorizations

able are today I for cytokine this have we're can XX to country think currently again, And moment, sell countries world, COVID-XX. be storm. positioned any we the that, the around we well used to of treat the treatment of in registered the at in we to current ability be because in that

to for did our use from necessary not be We Israel, therapy some COVID-XX. are from able authorizations and necessary. example, some again, to those get But approvals they're in So earlier, India. earlier not

Anthony Petrone

here thoughts, would and queue. in And be then maybe the I'll back get two

be Germany ramp on on really The how you the then just was terms to specifically. contributing rep an maybe of you know update when that expansion, just first it really, expansion. is timing this process begin ground And expect would little going. in terms just plant of sales the And in reference CytoSorb additional Germany, the begin bit sales maybe on to the actually time plant in to a a here sales you'll you take the U.S. as in to break force,

million level what expansion plan? support XXX to committed in CapEx that to mentioned million sales, of Thanks. You will XXX be but to

Phillip Chan

questions. good Sure. Anthony. Two

Germany. Dr. Let and me over then Marketing Christian great. the turn could President Officer VP our Operating second Capponi, you our That one, the be Sales one the Chief Steiner, take And first Vince of if would that Christian Senior Steiner, in one. and Christian?

Christian Steiner

Thank you, Phil. Thank Can the for you, you me hear question. right? Anthony

Anthony Petrone

yes. Yes,

Christian Steiner

force, end good. was of in we the of And for of force training also all first the this sales sales Germany, the terms quarter. sales Yet very year. year beginning the reps the Okay, last finished have finished in of in actually build-up

access everyone think to speed we as soon and to bring at on for still the and have go. QX, for I for the hospitals pandemic the restricted to reps as training think access sales to the them everyone quite from right ready Yes, had case is some sales sales that is we the we the on But in force. ready pace the can expand hospitals. I XXX% time that's I COVID-XX to reps regulations the the led has also think the

Phillip Chan

time. the And, CapEx Christian. Vince, for that, manufacturing if Great, question could take maybe and on requirements that you and

Vincent Capponi

Phil. Thanks, All Sure. right.

about capable product. build zero year, first out producing case, So on it's to approved have of actually in intending next are actually expenditure, that CapEx of us take it building to here which going quarter the close to and in and regarding we then months in and XX new your starting question potentially roughly

to as about able obviously, that's build on business. your be landlord answer I well million Did million support expect be as contributions with out of about to that a around We about to $X $XXX going question?

Anthony Petrone

you. Thank Absolutely. Yes.

Operator

B. Next go Riley. question ahead. Please Andrew with from D'Silva comes

Andrew D'Silva

Hey, Thank taking much you good afternoon. very questions. my for

to up you XX% the you'll year, as you think one, on to relates Two as current back manufacturing be margin follow parts, close that it gross Just at the facility. the level? You so XX% you without $XX there? incentive like noted produce the to, at number? that capacity ramp annual up seems have the full reached then And question, payments, do manufacturing near million out to ability almost you're

Vincent Capponi

Phil. So go ahead

Sorry…

Phillip Chan

to no, I it pass No, just on you Vince.

Vincent Capponi

for All question. right. Thanks, Andrew, the

Kathy So margins, respect gross at the you to we're XX%. as without the you incentives, with etcetera as could, around mentioned, roughly the the

close We take those expect etcetera incentives out, to you the expect be gross margin. we'll, to if XX% to be

Our we're efficiencies you now come balancing there. we've with completely to improving, again, expansion, not will for to we're are started demand. if as And up

is, capacity etcetera So now, we and bottom too is approved see will, Christian’s we gross close the you million the should million on relative think excessive the margin to as the being door that. I if incentives, want forecasting. Again, capacity, basically, full operation again, the our to that go be to With XX we're $XX don't here. balancing what to the of we respect orders at if taking line. we on But XX% out efficiencies knocking are very

product now and of out increase, will, velocity the you of you we between we've production parts, the to actually I parts certain help So will run added if of another which but the April than this line more, year, of plan. other will if we put could operation, of say

helped able this keep Does So that with that supply the to obviously, us Christians COVID-XX situation. market address… demand with and be with has up this,

Andrew D'Silva

or lines Yes, your there? now, two are

Vincent Capponi

lines. three lines at We're actually actually now. We're three

Andrew D'Silva

And clinical trials. your that. press the been clearly a to you're was internally release to for now related lot you stood side, shock. funded on on fairly Thank you hit. historically more in out bar septic a That's investing notable challenging perfect. Okay, then One

with see around right pursue Just you believe that any curious now whether versus now from could a that gives to you about differences standpoint, that. And, to if is confidence you time regulators you efficacy or talk go why before? the that

Phillip Chan

Makis, take yes, that? you Oh, like would to

Efthymios Deliargyris

the for bar that Yes. field clinical and trials everything testing academic should question. you. have against many away leaders reach. is you mortality, that since community the years alternative be the Sepsis randomized too measures in move Thank The high Thank that for and thought the from of to just suggested

regard, we years, saw recently into approved regulators on shock. recently few last people blood some line, fall vasopressor that pressure that in over the in and So based stabilization with

setting. So they to that clinical opportunity ability accepted to more now the clinically more are execute that it us of necessary regulators need improving makes fluids innovative the other now we by improve for are pressure, endpoints the for believe with and do levels the message to return that meaningful, hemodynamic getting to execute patients maintain and when CytoSorb the additional getting they a the now of mean especially patients that And to the clinical a as rid vasopressors reduction ventilator an drugs with the of studies, with the the because most septic connect to therefore two is treatment the and can stabilization, are field blood from considered this stabilized. in and be we're benefit pressure, users see the evident for the the consistent of that rapid immediate one shock arterial these trials

CytoSorb is a it confident can, can us, performance that in using of the endpoints it’s the endpoints can of of both looking we second innovative that into evolution we new can new into in everyday twofold. we for very us such trial compelling, practice we in community setting. academic his that show So of is clinical the all makes it's think highly trials. and A we regulators deliver we One, believe

Andrew D'Silva

just and the discuss lot. to just And development line. for could versus question last be that both you the thinking clients paths this a where from I you about there's It's are, related Okay, great. those. and just get you me opportunities, for if HemoDefend-VGA, HemoDefend-RBC, And product other should if any

Efthymios Deliargyris

contaminants a cell from other product, wide that cytokines, of HemoDefend lipids, the this potassium, reduce is bioactive cause can transfusion blood designed non-infectious red platelet such potential that contaminants with cells, is So as a and variety antibodies, product reactions. to blood

is Heart, And we've towards Lung And United would this subsidized its that discussed Blood apply this then as And for in approval a is so States. then Institute. human and potentially studies. we by was way clinical the program subsequently National making the for, in past,

that in because made to is bench program conduct very over of COVID-XX, the past has in it slowed need and much that because moving also of where, limited said, will volunteer studies. on we the point much post some still the it This studies, progress one to So, our several things healthy being COVID is is, essentially environment. additional very be forward pipeline months. a That we significantly and

HemoDefend whole is the create second production this area given coagulation where example, remove as unit. used and example universal are do That or a broad, patients patients specific. a in And and plasma to ill in plasma about plasmapheresis need antibodies of can plasma to or of chain worry a to product blood-type type anti-A not The guess program. used exchange supply trauma plasma processing to product as designed anti-B albumin and specificity broad a that is of factors for the such well plasma for and used in they factors the critically not actually that from shelf is and blood a program as is blood the that rapidly BGA way as be off I

that's second which a value then, combat in ability related for of superior trying the bleeding and the stop in universal transfusions, as military blood is one rather cells plasma whole example, the give its such to than giving pack in casualty red believes the hemorrhaging alternative platelets to So is of and application giving component And to terms injuries. blood to plasma. and

program a funding that is in this so eventually actually and have human now and this product And received to clinical this development X.X year, studies approval. advanced preclinical complete we million the to

half are the the outside a, the or It's so, get our of of to and this well a priorities to, And of out and year is funded program goal for, pre-clinical realm are so. this one next of a is CytoSorb. company moving within aggressively. the we and And,

that, work So everything think slowed etcetera. in the of, in has able has, I terms being to lab, COVID-XX down

these said, some lost we continuing forward. and are back But move now that R&D in folks we lab time So being there. to are our programs the

Andrew D'Silva

out And you year. progress thank on for the the of Okay, congrats luck all XXXX. this color closing best and

Efthymios Deliargyris

Andy. Thanks a lot,

Operator

Next Jennings Cowen Company. Josh question ahead. comes with go Please & from

Josh Jennings

good Hi, evening.

or strong the us two primary and ask thanks or on congratulations the potential to Secondly, could you for this trial, results. trials. had, see wanted the Hi, to STAR I call. about and wanted endpoints Phil, just endpoints trials help think the details those all secondary if about for on

start to that? Just with

Phillip Chan

Sure.

it Let Makis some Michael? me for turn just additional to over color,

Efthymios Deliargyris

and Phil, thanks you, the for Thank question.

So safe the acronym STAR stands timely and removal. for antithrombotic

the series studies application. is So the this STARX be is look registry. a to that for at the STAR of comprised program of important will idea different areas

CE As Mark you probably aware, we and for have removal ticagrelor approval Europe rivaroxaban. of in

been So that treated this cases is we user's happening a actually collected, have already now survey practice. over suggests way. have And now that that XXX in

real information, own complement informing capture itself. of are to establish approved and to the be STAR STAR with specifically into this drug removal drug studies And new and be doing programs reversal standard the and clinical as STAR drugs, will to in looking use, meant PK-PD measure per other the program X X able be compelling which obviously a believe and obviously, is by with STAR to will studies. detect this the to X its of effect in standard-of-care institutions of guidance, X as removal the FDAs publish world the The outcomes intent we data, very regions. to the So gold

an extensive using PK-PD Apixaban, such as anticoagulants doing or and So Rivaroxaban, dabigatran, we looking in utilize the trials. oral of the CyTATION, parameters one in of patients the at we're Ticagrelor with as the Cytosorbents or program, direct every and to TISORB plan

benefits have the comes So when randomized the definitive the drug most a obviously, but the reductions it X to removal bleeding start care, substantial to not provide reduction improvement around the will standard-of-care believe the those ones, of where trials, in before program tremendous data show approach basically clinical obvious PK-PD to also and sitting the It’s or associated meant clinical waiting clinical as we're operation a can then to unnecessary of in efficiency the in in these are value application of outcomes, has these and they this just those practice, of in implementation they're the to STAR today's that CytoSorb. economic wash today, stage for a it’s throughput We patients that proposition. intervention. hospital by this definitive late out And drugs is a mechanistic be going benefits.

provide STAR world them data. of evidence, course, drug and and removal, of many outcomes performance designed the picture then the platform economic to mechanistic of programs, So consists real of full the use, clinical all STAR,

Josh Jennings

a well follow Ticagrelor? just will X, include as NOACs on STAR on that patients And Excellent. up as

Efthymios Deliargyris

same Yes, of in indices also efficiency. the we we the that clinic again, the and has believe the that. believe reductions exact clinical in benefits, increase bleeding, application including, the Short,

So, to Ticagrelor invest plan data both on class. we generating so the in NOAC and

Josh Jennings

a for had critically that. patients ill patient indication Could based thanks to XXX the the data CytoSorb States? for registries that question worldwide. And for a COVID-XX submission use you U.S. the bunch Great, in on specific a then of registry registry, just registries United potentially for CTC, a of other

Efthymios Deliargyris

let me over the side. Phil, let regulatory or provide to to me more you So turn of Vince that

Vince, to that take or Phil want So one? you do

Phillip Chan

COVID-XX of is clinical of registry Yes, really data the think viral complications to of goal the Sepsis. the the and I treatment on generate

shock, complications of lung infections, variety that the an causing injury, out influenza and COVID-XX. turns Sepsis to these different particularly are kidney it And injury. viral So a common a just as virus, a in as injury, viral organ like COVID-XX example, for infections, is flu, such including leading wide and

are the in perennial, every States, alone, patients United XX, year, not XX,XXX the do but key year particular XXX,XXX drive every be influenza, to to the it is We data flu millions in XX,XXX and every and States. is to of will level in hospitalization, year, regulatory in from year XXX,XXX, be begin patients, a to back millions believe to approval, don't about So may the U.S. sufficient believe get other registry data deaths. which we XX,XXX of that comes studies who of happens Sepsis, XXs viral would provide countries, of leading about there it United sufficient which last able although XX million be

that think potentially definitive example, be of COVID-XX, study progress we basis. in that source we will any a so on-going can could with revenue flu, that do an perennial for And a for be leverageable make to us on

Josh Jennings

it just momentum about growth indications makes sense. questions think utilization mostly you and/or also And guys? XX% from Now, sequential talk my was sequential question, did or And Can taking nice related? you That that drivers? your revenue and channel. Ticagrelor Appreciate thanks. your some COVID the Or the see from team and last removal I distributors generated distributor -- the demand rivaroxaban thanks the for that.

Phillip Chan

turn to coming on give Christian and distributor it Sure, that's Christian? to me Josh, sales, where color the let over some from?

Christian Steiner

Josh, that whole think Thank you. that's Thank the But Yes, a not the assuming I for question. in you're, story. you're you, COVID plays right role.

for this and So I been are in many countries, countries, markets years. we currently to long time partners. XX that takes And than the think the few prepare has quite as in in a more months and last together

we at use a demand. start infrastructure when COVID in. And us markets head the the could countries And kicked and gave cover so of this kind in quickly that these ready the and, countries or the were time

So drove on indications, our on the it's continuous one and a was by the kick both. standard really It's, on hand COVID-XX.

Josh Jennings

Excellent. Thank you.

Christian Steiner

sense? Does it make

Phillip Chan

this know, Latin think shows we year. which America, example, I also, opened you Yes, for just

longer market in actually, ramp expected We many Latin fact, in penetration America. to countries within a much

that pandemic and other countries COVID-XX throughout Latin places and many the like America. accelerated usage Colombia, has adoption, However, really

benefit, into applications been or help should And we usage have away, the to well. positive the that a think, outcomes as so translate goes I as positive that lasting when COVID-XX other that see outcomes going even they've seeing and

Josh Jennings

those for Thanks Great. details.

Operator

Antalffy comes ahead. Danielle Leerink. from go Please SVB question Next with

Danielle Antalffy

so Hey, I on much afternoon, appreciate Thanks it. call, the initiating for since question taking first everyone. coverage. my good

So Joshua's as to procedures Europe. other the the we COVID? come up contributing they follow being it's question, it's how elective hope just number end think about mean, in the of I of done indication limited, on out do NOAC on

qualitatively be if some give it And us even about think we about ramp, color Or have up. thinking like, hope elected So procedures there? could should line if you in a we one with I ramping? follow there

Phillip Chan

have great terms you the the do and feel mute. Sure. to that with we Ticagrelor will discussing Mikas, develop Thanks, you on take be on the to Danielle. NOAC? Mikas, of market also how removal, that And may in call. want you

Efthymios Deliargyris

like of now, most to around all many an Apologies. the for application new and these been throughout need patients the by for the anticoagulants, Cornerstone Thanks, the are increasing relates question. have considered for the drugs of long it's last there patients. novel over many rivaroxaban, and coumadin available These replacing for the drugs is course, it this penetration world Daniel, oral And cardiac And among Ticagrelor, apixaban anti-thrombotics, be been decades. generations, time. couple which that a as cardiovascular and Ticagrelor are of unmet best-in-class, only years are that's both

an emerging for with and urgent So been operation. these require with this having it problem sense management in many care, they've or frequently, either stuck years. these many, are the requiring an accident And stuck of patients these clinicians doctors,

right do solution market in the that there no need. and need unmet is is now. this very the The you not unmet need clear difference develop So is to

this So we them when present evidence getting can response tell physicians common use. from for most a you that this we're the to no-brainer for application is that the we is

support early we opportunity as education more we So a these our necessary this as view continue clinical feel even a we rapid obviously, with it a the we're long so, the managers patients. information. transition see and slow ramp-up, data We we now for then for communication an standard-of-care have that we see as clinical of this to for of more adoption data of don't rapid clinical to and generating as and

Danielle Antalffy

Great...

Phillip Chan

think... I

Danielle Antalffy

ahead, Go Go Phil. that. Thank you for ahead.

Sorry.

Phillip Chan

sorry. Oh,

release really because conferences, are part sales about it's training limited and that's of ticagrelor get detail been and and as as our we out of in and those used, that have Makis year think And and And medical the hospitals this in talk we I fact received I have technology approvals that press them to who the rivaroxaban earlier mentioned major -- mentioned. in the made COVID-XX, from them how that in terms think it, to we not educate of terms don't bring about contributions know able also there well. have them and is being need been, for yet. the of issue there I that

uptick I usage. think I so, leverage able this all in really think then, now out to when significant our resources the commercial of we to that clinicians And and will world, see bring to that are a is COVID-XX, over you come once significant

Danielle Antalffy

Got it.

Phillip Chan

feedback know about who Those it, getting. we've been a it really that the lot, like that's and

Danielle Antalffy

Yes.

follow-up just that. So on a

in indication you about -- presumably, the So curious just upcoming how so U.S. think EUA, already go-to-market a in as we the about have think you're good Terumo. given and COVID already centers some to and you're the strategy, partner

thinking those into ramp but about should help already color way it's some So still how critical centers us gives of appreciate there the the versus maybe we an here, the there. color on even to have in you setting, to us I cardiac qualitatively, entree setting U.S. number experience? give that care quickly presumably some system centers is give be and the have a this

Phillip Chan

Yes.

was technology a blood machine are about thing with CytoSorb main opportunity lungs patients cardiac Officer, Officer, who the it that the had in Robert invented to introduce technology throughout oxygenation, using actually modalities of surgeons can that and So is support represents Dr. Medical do an to the that outside the is the that oxygenated a called our surgery respiratory thousands to these of of over terms where of a not said, perfusionist the Bartlett, -- is which we CytoSorb growing ventilation one fact rescuing COVID-XX modality why patients I artificial Typically, think But reasons because this Chief the being centers. ventilation -- of Chief that former of market the when the mechanical extra-corporal exciting world. years fail will designed who uses die diseased that's membrane ECMO, off-label we've the one former and body in fails. ECMO, by our Medical by get mechanical so patients

is reduce systems. as they inflammation concept extra with easy what -- of getting deadly are to the also, reduce and hook-up to is use CytoSorb to a of experience cytokines However, to the corporal improve to how it means

regulatory those go, we be to prime the look So this, if approval get and that be actually believe that U.S. and and of launch we when basis to we will will effort. ready when centers commercialization hopefully

us in obviously at they We being major and for clinical represent the in also Coast here throughout centers cardiac the XX targets also on studies the example in for focus. run United done surgery is East States, initial centers, particularly REFRESH-X the commercialization country, a

program. is if in you developing One the with maybe begin But efforts going and are commercialization here United can keep doing want I the this are leading we Vince of or? actually our and is actually about things we that working that, or to Vince, States to it talk

Danielle Antalffy

no. Yes

Vincent Capponi

sorry, Daniel. on going. ahead, Phil, keep Go

Phillip Chan

the United the also last. the States. play a of in a to that manage States. will into Well, because role hiring opportunity believe commercialization Sales in that process not takes Healthcare again while person, one, in VP QX. And Marketing organization the And help COVID-XX the person and it QX for of we we that U.S. to we is Okay. continue are actually so it goal United a well through and are dominant time, COVID-XX But of

R&D, non-clinical not where a our manufacturing but our we headquarter is U.S. commercialization We and is, quality, are our our are this -- is organization this do where all of a the in and clinical we

takes it as know. that to time And you so, build

or to infrastructure be so, support strategy that effort. of of United not partner and to of States the rolling building in whether going one the or strategy then be a it's goals direct that that up here and with coming is out able to the And

we can -- leading right short will detail guess more time be bit a Vince now. effort give now strategy. leading a So And be just will it that I little on is that that till you

Danielle Antalffy

thanks. helpful, That's

Phillip Chan

Sure.

Operator

Lee HC question ahead. Please Next go Sean from Wainwright. comes with

Sean Lee

quarter afternoon a and guys. for my taking questions. great Congratulations Good on thanks

Phillip Chan

Sean. Hey, Sure.

Sean Lee

quick questions programs. two the clinical I have just on

bit the and a strategy provide as you both as color future have on that see could well you study So study. first, U.S. Sepsis? tackling for I more your planned a the German

more about study are endpoints any little a studies U.S. us tell can study? these there potential between the you the whether of and design and the German and what are maybe differences So the

Phillip Chan

Sure. you or would that can it Makis, as take well? like to take I

Efthymios Deliargyris

Phil, or your call. Either

Phillip Chan

don't go Sure. you Why ahead?

Efthymios Deliargyris

Okay, great.

thanks Sean, the So for question.

present multi-center a going And mentioned the is And Germany, is shock trial goal in be earlier care patients to process patients. Septic to I the treatment themselves hemodynamic what we the when be trial, will to call, that by tends reversal, demonstrate that's execute units. idea shock targeting to the stabilization, in in shock the will in -- these that's another which one they attempt intensive reversal. term So we number is which here

first to do be all the apply need you to hemodynamic thing stabilize the is therapies. to other The able

endpoint, patients primary specifically get the these stabilized. a time implemented have to we detecting So

similar time event, the Sepsis. So because a acute the hypo where progress we every minute the The like dependent very it's counts, know organ higher a cardiac will likelihood that situation organs manner, just in in to are procured, its these failure. longer

studies studies a need executing were endpoints kind the is that previous today it's innovative endpoint. It's mortality presented regulators an on -- at a clinical in of starting are have using very setting. negative, because of that kind So are to of believe the we earlier kind simply removed be meaningful this a believing endpoint. of as I to the looking the we to interest call, believe But

experience based to CytoSorb as would we they're we the engage that FDA by initial plan sure analysis early of meaningful focus stabilization a We with trial. are a that Executive always well. on and U.S. on And that's and make relevant use, German halfway trial, and we progression the endpoints. next That's PIs to trials. process of seeing the in identifying information feel meant to that's for through creating the of very trial of the So we us, the of patients provided issues. The an some in be commercial end the we're interim with the have human that to informative consistent getting report believe discussing for the going Committee, Septic that whatever we similar use the considered agency the again endpoints

XXXX. to do to currently before be in So we planning trial this anticipate launch early the able stages are we And of it.

Sean Lee

Great. ongoing second on question TISORB for Thank the is and color. additional My the CyTATION studies. you

those impact timeline results the wondering what's whether with those? potentially flare-up the Europe, can can we of on see of you the Now, and maybe the update was -- those COVID on I studies in from on when

Vincent Capponi

The question. shutdowns study the before effect. Yes, was TISORB, enrolled great activated actually and COVID took the first right patient its

R&D that's restrictions on an that teams COVID-XX study So active CRO-related and the clinical Scotland. have and have and both basically navigating U.K. been both been the our internal imposed in team the the team working related

seen to And already the patients have now eight Having that, We the are these out last over Europe seeing the starting said wave TISORB. U.K. also six easing that enroll active weeks are looking we we to some play second in now sites including have requirements. of to throughout

restrictions possibility a there So in may impact the sites. of our is will do we that additional we don't come exactly know this how near But expect future.

beds Regarding of COVID have to IRB is CyTATION, of is We have multi-center a the regarding a in did That second intensive critical being impact get on lighter some CyTATION made study more, as in progress regulatory and little about approvals to Germany. wave Germany started. kind recently the has how executed in a study. as much know, a much Germany surge higher first We wave. care don't manage greater Germany. cases. exactly impact numbers you of capacity know the will much in But

both at wave out. at same are plays may impose carefully we progressing what time, second So But the trials. COVID-XX we're looking as the

Sean Lee

all Got Thanks for it. have. questions. my I That's taking

Phillip Chan

Great, Sean. you. Thank

Operator

turn I closing to additional time, would to this any back management or At remarks. like for it

Phillip Chan

everyone we much. to And to and not please answer did participation next you have thank you Well, We do out very everyone if we'll thank to to the your any Feffer for free try reach other possible. quarterly Jeremy forward feel a Have night. call. look your questions questions good you And you where jeremy@lifescienceadvisors.com today, at that today. reply to

Operator

today. for conference their for to concludes like participation. That everyone thank you. our I Thank

Cytosorbents (CTSO) 4 Nov 202020 Q3 Earnings call transcript